5 years results: endovenous treatment of superficial vein ... · EVLA: Endovenous Laser Ablation...

5 years results: endovenous treatment of superficial vein reflux in an outpatient setting

Insoo Park, M.D. Charm varicose vein surgery clinic

Seoul, Korea

ENDOVENOUS TREATMENT

: 5 YEARS RESULTS?

EVLA (Endovenous laser ablation)

RFA (Radiofrequency ablation) - Radiofrequency segmental thermal ablation

RADIOFREQUENCY SEGMENTAL THERMAL ABLATION

: CLINICAL DESCRIPTION

The RFA ClosureFast™ system,

delivers radiofrequency energy in a controlled fashion

segments of veins causing denaturation of the collagen

contraction of the vessel

no blood can flow through it

7 cm

3 cm

EVOLUTION OF CLOSUREFAST™ TECHNOLOGY

FDA cleared Closure™ System

1995 1999 2006 2009 2015

VNUS Medical Technologies Founded

Covidien acquires VNUS Medical Technologies

Medtronic acquires Covidien

2014

FDA approval ClosureFast™ System (segmental ablation)

FDA approval ClosureRFG™ Generator (RFG3)

FDA cleared ClosureRFS™ Stylet

2005

RADIOFREQUENCY SEGMENTAL THERMAL ABLATION

: LONG TERM STUDY

ClosureFAST study Multicenter, prospective, 5 years f/u

Alan Dietzek. Veith Symposium New York City; November 19, 2013

Rassumussen study Multicenter, randomized, 3 years f/u

Rasmussen LH, et al., J Vasc Surg Venous Lymphat Disord Oct2013;349-356.

Proebstle study Multicenter, prospective, 5 years f/u

TM Proebstle , et al., BJS 2015 Feb;102(3):212-8

Dietzek A. RF Segmental ablation: 5-year data. Annual Symposium on Vascular and Endovascular Issues, Techniques, Horizons (Veith Symposium) New York City; November 19, 2013

CLOSUREFAST STUDY

Study Features:

International multi-center study (8 Europe, 5 US)

Prospective, longitudinal, single arm

326 patients and 396 limbs treated

278 limbs followed to 5 years (70.2%)

Dietzek A. RF Segmental ablation: 5-year data. Annual VEITH Symposium New York City ; November 19, 2013

: Dietzek A et al. 2013

Primary Endpoints

Vein occlusion rate

Absence of reflux rate

Secondary Endpoints

Presence of complications and side effects

Quality of life (QOL)


CLOSUREFAST STUDY : Dietzek A et al. 2013

BASELINE CHARACTERISTICS

Enrolled Subjects (N=326)

Age mean (SD)

Age range

50.8 (13.3)

18 - 79 years

Gender 73.3% Female

26.7% Male

BMI mean (SD)

BMI range

26.5 (5.6)

16.2 - 48.5

BMI = Body mass index



OCCLUSION RATES AT 1 & 5 YEARS

90.0% success at 5 years

96.6% success at 1 year



OCCLUSION & REFLUX FREE RATES

Time

Occlusion Rates %* Std Error

1 Year 96.6% 0.9%

2 Year 94.3% 1.2%

3 Year 92.8% 1.4%

4 Year 91.1% 1.5%

5 Year 90.0% 1.7%

*Product limit occlusion estimates.



Time

Reflux free Rates %* td Error

1 Year 98.9% 0.5%

2 Year 97.8% 0.8%

3 Year 95.7% 1.1%

4 Year 94.0% 1.3%

5 Year 93.7% 1.3%

RASMUSSEN STUDY

Study Features :

Randomized, prospective trial, two sites Denmark

500 subjects (580 legs)

Patients assessed at 3, 30 and 1 & 3 years (intended 5 year follow-up)

Compared 4 treatments : EVLA (980 nm and 1470 nm) – 125(144)

RFA ClosureFast™ catheter – 125(148)

Ultrasound guided sclerotherapy (UGSF) – 125(144)

Surgical stripping – 124(142)

Rasmussen LH et al., Randomized clinical trial comparing EVLA, RFA, FS, and stripping for GSV with 3 yr follow-up. J VS Venous Lymphat Disord 2013;349-356.

: Rasmussen et al. 2013

Primary endpoint Closed or absent GSV

(Refluxing segment 10cm or more considered failure)

Secondary endpoints Presence of varicose veins, reoperations, VCSS and QOL


RASMUSSEN STUDY : Rasmussen et al. 2013

EVLA: Endovenous Laser Ablation 980-nm diode laser 17 legs & 1470nm diode laser 127 leg,;GSV, Great Saphenous Vein; RFA, Radiofrequency Ablations;

USGS, Ultrasound-guided Foam Sclerotherapy.

RASMUSSEN STUDY


RASMUSSEN STUDY BASELINE CHARACTERISTICS

RFA EVLA UGFS Stripping

No. of patients 125 125 125 124

No. of legs 148 144 144 142

Bilateral 23 19 19 18

Age (range) 51 (23-77) 52 (18-74) 51 (18-75) 50 (19-72)

Female (% ) 70 72 76 77

CEAP C2-C3 (%) 92 95 96 97

CEAP C4-C6 (%) 8 5 4 3

EVLA: Endovenous Laser Ablation 980-nm diode laser 17 legs & 1470nm diode laser 127 leg,;GSV, Great Saphenous Vein; RFA, Radiofrequency Ablations;

USGS, Ultrasound-guided Foam Sclerotherapy.



OPEN OR REFLUXING GSV’S

Kaplan-Meier (KM) plot of reoperations. The KM figures represent time to the event.

Treatment Number %

RFA 8 7%

EVLA 8 6.8%

UGFS 31 26.4%

stripping 8 6.5%

EVLA: Endovenous Laser Ablation ;GSV, Great Saphenous Vein; RFA, Radiofrequency Ablations; USGS, Ultrasound-guided Foam Sclerotherapy.

RASMUSSEN STUDY : Rasmussen et al. 2013


VCSS (Venous Clinical Severity Score) :

Improved significantly in all groups (p<.0001), no significant difference between

groups at any given point in time and continued throughout the 3 year follow-up.

AVVSS (Aberdeen Varicose Vein Symptom Severity Score)

Improved significantly in all groups from day 3 through year 3 (p<.0001), no significant

difference between groups throughout.

SF-36 Scores (Quality of Life)

Significant improvements made over baseline in the following categories; physical,

bodily pain, vitality, and social functioning, in addition to emotional and physical

component summary in all groups at all times.


RASMUSSEN STUDY


PROEBSTLE STUDY

Study Features: European multi-center (8 sites in Germany, France)

Prospective, cohort study

Between April 2006 ~ March 2007

225 patients and 295 limbs treated

177 patients and 236 limbs followed to 5 years (78.7%)

: Proebstle et al., 2015

Proebstle et al., 5 yr results from the proepective European multicenter cohort study in RF segmental thermal ablation for incompetent GSV BJS 2015 Feb;102(3):212-8

PROEBSTLE STUDY : Proebstle et al., 2015

Primary endpoint : Vein occlusion

Absence of flow in the treated vein using distal augmentation

Secondary endpoints : CEAP, VCSS, VAS for pain, complications etc.



Mean diameters

of GSV 3cm distal

to the SFJ

Not visible in 53.4% at 5

years

Fibrotic cord mean 2.0mm (preOP mean 5.8mm)



GSV occlusion rate

at 5 years : 91.9%

(complete occlusion with

absence of any reflux up to

3cm below SFJ)



VCSS

Baseline mean 3.9(2.1)

reaching 1.3(1.7) at 5 years


RFA CLOSUREFAST ™ CATHETER : SUMMARY

Occlusion rate :

3-yr follow up 93% (Ramussen et al.)

5-yr follow up 90% / 91.9% (Dietzek / Proebstle et al.)

Significant improvements

: VCSS, AVVSS, SF-36, pain VAS

My experience of RF segmental ablation (ClosureFast™) 1st case on 11 Nov 2014

Subjects (N=291)

Age mean (SD)

Age range

43.3 (15.4)

18 - 76 years

Gender 80.8% Female

19.2% Male

BMI mean

BMI range

23.5 (3.5)

15.8 - 42.7

More than 3 mo

More than 6 mo

More than 1 yr

224 150 50

No. patients

My experience of RF segmental ablation (ClosureFast™) 50 patients reached up 1 year of postop period

32/50 patient followed to 1 year (63.3%)

1 patient showed recanalization by perforators in lower thigh

Occlusion rate 96.8 % at 1 year

Stripping 45%

RFA 28%

EVLA 27%

My procedures

Thank you

E-mail : prs3131 @ naver.com

5 years results: endovenous treatment of superficial vein reflux in an outpatient setting

Insoo Park, M.D. Charm varicose vein surgery clinic

Seoul, Korea

5 years results: endovenous treatment of superficial vein ... · EVLA: Endovenous Laser Ablation...

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